| CAS No. | CATO-C4X-154284 |
| Molecular Formula | C20H33NO2 |
| Molecular Weight | 319.48 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO manufactures Amorolfine Impurity 84 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
As a process- or degradation-related impurity, Amorolfine Impurity 84 (CAS CATO-C4X-154284, C20H33NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Amorolfine Impurity 84 (C20H33NO2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
| Molecular Formula | C20H33NO2 |
| Molecular Weight | 319.48 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | ≥95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |